1. Field of the Invention
The present invention relates to a face mask apparatus, and more particularly, to a face mask apparatus for sleep apnea treatment, and methods of making same.
2. Description of the Prior Art
Sleep apnea is a condition characterized by pauses in breathing or shallow breaths while sleeping. The pauses in breathing may last for a few seconds to a few minutes, and may occur more than 30 times an hour. Left untreated, sleep apnea leads to excessive daytime sleepiness and an increased risk of high blood pressure, heart attack, stroke, obesity, diabetes, and heart failure.
Treatment options for sleep apnea generally include lifestyle changes (e.g., weight loss, avoiding sleeping on one's back, avoiding alcohol, smoking cessation), surgery, mouth pieces, and breathing devices. The most common treatment for sleep apnea is a continuous positive airway pressure (CPAP) or automatic positive airway pressure (APAP) device. These devices blow pressurized air via a hose to a nasal pillow, nose mask, or facial mask at a pressure high enough to splint the airway open during sleep.
It is known in the prior art to provide sleep apnea treatment medical devices. Currently, masks are made from plastic, and are adjusted by either foam or gel to suit the comfort level of the patient. In addition, the gel or foam is also utilized to form the seal between the mask and the patient's skin. The seal is an important part of the effectiveness of the mask because it ensures that air does not leak out.
It is also known in the art to provide customizable masks for facial application. It is further known in the art to use computer aided design for custom face mask design and manufacture. And it is also known to provide three-dimensional (3D) facial data for use for fabrication of a custom fit mask for medical procedures.
Examples of relevant prior art reference documents include the following:
U.S. Publication No. 20120305003 for “Rapid Production Of Customized Masks” by inventor Mark, filed Oct. 21, 2009 and published Dec. 6, 2012, is directed to a system designed for the rapid preparation of anatomically customized mask employing data from a patient. The data may take the form of a multidimensional image of a target area of a patient's face obtained by optical 3 dimensional imaging, or a dot or line scan form laser imaging, pattern laser photography or stereo photography. Also disclosed is a mask that is made of a thin layer, so it is lightweight and closely hugs the targeted region upon which it rests (e.g. the nasal region). The body of the mask is made of a thin layer, so it is lightweight and closely hugs the targeted region upon which it rests (e.g. the nasal region). Methods for producing anatomically customized masks are also described.
U.S. Pat. No. 5,280,305 for “Method and apparatus for forming a stylized, three-dimensional object” by inventors Monroe et al., filed Oct. 30, 1992 and issued Jan. 18, 1994, is directed to a device that produces a three-dimensional object with custom art work from an electronic signal. More particularly, the preferred implementation is a device for making masquerade-type masks, and includes a digital camera that captures a front-on image of an individual's face and converts the captured image to an electronic signal that is downloaded into a personal computer. The computer is utilized to select an image, process that image to remove background, scale the image to correspond to the dimensions and features of a facial die that will be used to mold the mask, and to provide for special effects processing of the selected image. An ink jet plotter is then directed to print the processed image upon thin, flat plastic, which is aligned with the facial features of the die and deformed to skin tight conformance with the die by a vacuum-forming process. The finished mask bears art work, upon its convex exterior, that realistically imitates the face of the individual which served as the model for the mask.
U.S. Pat. No. 4,985,116 for “Three dimensional plating or etching process and masks therefor” by inventors Mettler et al., filed Feb. 23, 1990 and issued Jan. 15, 1991, is directed to a process for plating or etching metalization patterns on the surface of a three dimensional substrate, wherein a flexible plastic mask is fabricated by first coating the surface of a thin plastic sheet with vacuum formable ink. The mask is then molded into the shape of the surface into which the pattern is to be formed. A low power YAG laser is used to remove areas of the ink through which light is to be allowed to pass. This mask may then be used in either a print and plate process or a print and etch process by drawing the mask into intimate contact with the workpiece by applying a vacuum between the mask and the workpiece. The workpiece may then be exposed to light through the clear areas of the mask.
U.S. Pat. No. 8,020,276 for “System and method for custom-orienting a medical mask to an oral appliance” by inventor Thornton, filed Nov. 29, 2007 and issued Nov. 20, 2011, is directed a medical mask including a body and an orientation structure. The body includes a first polymer, is configured to cover portions of a user's face comprising the user's mouth and at least portions of the user's nose comprising the nostrils, and is further configured to contact the user's face surrounding the covered portions of the user's face to substantially prevent gas from escaping between the body and the contacted portions of the user's face. The orientation structure is configured to receive an oral appliance post to establish and maintain a custom orientation between the medical mask and the oral appliance post and the orientation structure includes a deformable material which includes a second polymer capable of transitioning between deformable and non-deformable states.
U.S. Pat. No. 8,254,637 for “Mask fitting system and method” by inventors Abourizk et al., filed Jul. 26, 2007 and issued Aug. 28, 2012, is directed a system and methods for selecting a mask system for a patient, where certain example embodiments include generating 3D contours of patients and selecting mask systems based at least on those contours. These contours may be generated by using, for example, a cushion of translatable pins, a nasal cannular scanning device, and/or a shadow stereopsis sensor. Certain other example embodiments allow images and/or videos to be captured and optionally synchronized. Then, images of various mask systems may be overlaid to determine how well a mask system fits. In still other embodiments, a user can hold a transparency corresponding to a mask design in front of the patient's face to determine how well a mask system fits.
U.S. Pat. No. 7,827,038 for “Mask fitting system and method” by inventors Richard et al., filed Jun. 6, 2005 and issued Nov. 2, 2010, is directed to a mask fitting system for selecting a mask system for a patient includes at least one terminal which receives data unique to a patient. The patient data can be scanned in using a scanner, such as a handheld or 3-D scanner, or the relevant dimensions of the patient can be simply input into the terminal. A database is provided to store mask system data relating to a plurality of potential mask system solutions for the patient. A communication channel is provided by which the data received by the terminal can be compared with mask system data stored in a mask system database, so as to generate a best-fit mask system result. The best-fit result may include one or more mask system recommendations for the patient.
U.S. Publication No. 20060023228 for “Custom fit facial, nasal, and nostril masks” by inventor Geng, filed Jun. 10, 2005 and issued Feb. 2, 2006, is directed to a process for fabricating a facial mask to custom fit a patient's face for a comfortable fit for facilitating various medical procedures including the steps of generating a 3D data set to define a portion of a patient's face to be fitted with a custom mask, fabricating a patient's mask utilizing a patient's 3D facial data set, and fitting a patient with a custom fit facial mask for facilitating a desired medical procedure.
U.S. Publication No. 20040263863 for “System and method for design and manufacture of custom face masks” by inventors Rogers et al., filed Jan. 27, 2004 and issued Dec. 30, 2004, is directed to methods and systems for forming face masks. Embodiments may utilize computer-aided design and computer-aided manufacturing to form custom fitted face masks. System software may be configured to acquire facial topography information, design a mask based on the topography information, and send mask information to a computerized manufacturing device. The software may communicate with a scanning device for facial topography acquisition and a milling machine for pattern fabrication. In an embodiment, the scanning device may include a linear scan non-contact laser imager. In an embodiment, the scanning device may be manually moved with respect to an individual being scanned, thereby eliminating the need for motive apparatus. In such embodiments, position information may be determined based on data from a position sensor coupled to the scanning device.
U.S. Publication No. 20100199992 for “Cushion inside a cushion patient interface” by inventors Ho et al., filed Apr. 27, 2010 and published Aug. 12, 2010, is directed to a patient interface device that includes a mask shell and a cushion assembly. The cushion assembly includes a seal cushion and a support cushion. The seal cushion contacts a first area of a patient's face to form a seal therewith. The support cushion defines a second area over a face of such a patient when the patient interface device is being worn. The second area overlaps at least a portion of the first area.
U.S. Patent No. 20100258133 for “Face mask” by inventors Todd et al., filed Nov. 11, 2008 and published Oct. 14, 2010, is directed to a mask assembly for delivering gas to a patient that includes a mask body and a breathing circuit interface. The mask body includes an opening for reception of the gas and includes a seal structure for sealingly engaging with the face of the patient and surrounding at least the nose and mouth of the patient. The breathing circuit interface includes a first portion rotatably connected with the mask body and a second portion that is constructed and arranged to releasably connect with a conduit for delivering the gas to the patient through the opening.
U.S. Publication No. 20080060648 for “Stability Medical Mask” by inventors Thornton et al., filed Sep. 11, 2007 and published Mar. 13, 2008, is directed to a medical mask including a rigid sealing portion configured to cover and seal around at least a portion of a user's nose including the user's nostrils and a rigid stabilizing frame coupled to the rigid sealing portion. The rigid stabilizing frame includes a generally horizontal upper support member configured to bear against the user's forehead, a generally vertical support member coupled between the rigid sealing portion and the upper support member, and lower left and right support members coupled between the rigid sealing portion and the upper support member and configured to bear against the user's cheeks. The rigid stabilizing frame defines two openings configured to allow the user to see through the medical mask when the medical mask is positioned on the user's face.
WIPO Publication No. WO2013026091 for “Manufactured to shape headgear and masks” by inventors Dunn et al., filed Aug. 21, 2012 and published Feb. 28, 2013, is directed to a headgear or headgear segments that are manufactured to shape thereby producing little or no waste material. Techniques such as knitting, braiding, crocheting, and 3D printing can be used produce the headgear.
U.S. Pat. No. 5,492,116 for “Respiratory mask with floating seal responsive to pressurized gas” by inventors Scarberry et al., filed Jun. 3, 1994 and issued Feb. 20, 1996, is directed to a respiratory mask adapted to confront the face of a user in a manner to float with respect to the user's face on a cushion of gaseous medium contained within the mask for user breathing, the gaseous medium being contained within the mask by a flexible seal means carried by the mask and maintained in sealing engagement with the user's face while providing essentially no structural support for the mask with respect to the user's face.